BACLOFEN

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

HOSPITALIZED PATIENT [HOSPITALISATION]. NO AIR OR FLUID FLOWED THROUGH THE TUBING- THE TUBING WAS CONFIRMED TO BE UNCLAMPED AT THE TIME. [DEVICE DEFECTIVE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF EVENTS DEVICE DEFECTIVE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 13-MAR-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACIST VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON LIORESAL (BACLOFEN) INJECTION. ADDITIONAL FOLLOW-UP (#1) INFORMATION RECEIVED ON 16-MAR-2026. SIGNIFICANT FOLLOW UP (#1) INFORMATION WAS RECEIVED FROM PHYSICIAN VIA AN EMAIL. ADDITIONAL INFORMATION INCLUDED PATIENT DETAILS (PATIENT NAME, DATE OF BIRTH), SUSPECT PRODUCT DETAILS (STRENGTH, NDC, BATCH NUMBER, EXP. DATE), PROCEDURE. EVENT NO ADVERSE EVENT WAS DELETED NEW EVENT HOSPITALISATION WAS ADDED. EVENT VERBATIM UPDATED FOR DEVICE DEFECTIVE AND NARRATIVE UPDATED. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 40 MG/20 ML (2000 MCG/ML), INTRATHECALLY (NDC: 70121-2503-1, LOT NO: 8325201, EXP.DATE: 03-JUL-2027, LOT NUMBER ON KIT WITH THE TUBING: MS1435 AND SERIAL NUMBER: (B)(6)) (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION AND MEDICAL DEVICE REPLACEMENT ON (B)(6) 2026. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE CONNECTOR TUBING THAT CAME WITH IT BACLOFEN KIT WAS NOT PATENT WHILE DOING REFILL ON A PATIENT. NO AIR OR FLUID FLOWED THROUGH THE TUBING; THE TUBING WAS CONFIRMED TO BE UNCLAMPED AT THE TIME. THEY BELIEVE THIS IS THE SECOND TIME THIS HAPPENED. UNFORTUNATELY, THE TUBING WAS NOT SAVED/SEQUESTERED TO SEND BACK. ON (B)(6) 2026, THEY PERFORMED A RESERVOIR CHECK FOR A HOSPITALIZED PATIENT. SINCE THEIR INPATIENT PHARMACY ONLY HAD 20CC KITS IN STOCK AND THEY INTENDING TO REFILL THE PATIENT'S 40CC PUMP, SO THEY HAD TWO BOXES AT BEDSIDE, EACH CONTAINING A REFILL KIT AND ONE 20CC MEDICATION VIAL. THEY OPENED ONE OF THE REFILL KITS AND, BECAUSE OF WHAT HAD HAPPENED A FEW WEEKS PRIOR, THEY CHECKED THAT AIR WAS FLOWING THROUGH THE TUBING DURING SETUP. THEY FOUND THAT IT WAS AGAIN NOT PATENT, SO THEY OPENED THE SECOND REFILL KIT, CHANGED GLOVES, AND PERFORMED AN UNCOMPLICATED RESERVOIR CHECK AND REFILL USING THE TUBING FROM THE SPARE KIT. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO HOSPITALISATION WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE UNKNOWN. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO DEVICE DEFECTIVE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS HOSPITALISATION AND DEVICE DEFECTIVE WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF DEVICE DEFECTIVE AS RELATED TO THE LIORESAL REFILL KIT AND DID NOT ASSESS THE CAUSALITY OF EVENT HOSPITALISATION WITH RESPECT TO LIORESAL. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 14-APR-2026. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. AS PART OF THE INVESTIGATION, THREE (3) PHOTOGRAPHS OF THE PRODUCT AND ONE (1) USED, UNCONTAMINATED SAMPLE WERE PROVIDED. THE SAMPLE AND PHOTOGRAPHS WERE VISUALLY AND PHYSICALLY EVALUATED. THE IMAGES DOCUMENTED THE OVERALL DEVICE, INCLUDING AN IMAGE OF THE INTERNAL PORTION OF THE MALE LUER. PHYSICAL OCCLUSION TESTING WAS PERFORMED ON THE RETURNED SAMPLE AND FAILED. DURING EVALUATION, EXCESS SOLVENT WAS OBSERVED IN THE BONDED JOINT BETWEEN THE TUBING AND THE MALE LUER, CONFIRMING THE PRESENCE OF A PRODUCT DEFECT. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE FOR THE REPORTED LOT NUMBER IDENTIFIED NO ABNORMALITIES OR NONCONFORMANCES DURING MANUFACTURING OR FINAL PRODUCT INSPECTION. THE ROOT CAUSE OF THE DEFECT WAS DETERMINED TO BE OPERATOR OVERSIGHT DURING THE MANUAL ASSEMBLY PROCESS, RESULTING IN UNINTENDED APPLICATION OF EXCESS SOLVENT. ALTHOUGH OPERATORS ARE TRAINED AND QUALIFIED, THE MANUALLY ASSEMBLED NATURE OF THE PROCESS RELIES HEAVILY ON INDIVIDUAL ATTENTION TO DETAIL. THE INCIDENT INFORMATION WAS FORWARDED TO THE MANUFACTURING DEPARTMENT TO INCREASE AWARENESS AND HAS BEEN INCLUDED IN ONGOING TREND ANALYSIS OF THE PRODUCT LINE. THE COMPLAINT WILL BE RETAINED FOR REFERENCE, AND SIMILAR REPORTS WILL CONTINUE TO BE MONITORED. LAST ACTION TAKEN WITH LIORESAL (BACLOFEN) IN RELATION TO DEVICE OCCLUSION WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE DEVICE OCCLUSION EVENT WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.

Description of Event or Problem

HOSPITALIZED PATIENT [HOSPITALISATION]. NO AIR OR FLUID FLOWED THROUGH THE TUBING - THE TUBING WAS CONFIRMED TO BE UNCLAMPED AT THE TIME. [DEVICE DEFECTIVE] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF EVENTS DEVICE DEFECTIVE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 13-MAR-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACIST VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON LIORESAL (BACLOFEN) INJECTION. ADDITIONAL FOLLOW-UP (#1) INFORMATION RECEIVED ON 16-MAR-2026. SIGNIFICANT FOLLOW UP (#1) INFORMATION WAS RECEIVED FROM PHYSICIAN VIA AN EMAIL. ADDITIONAL INFORMATION INCLUDED PATIENT DETAILS (PATIENT NAME, DATE OF BIRTH), SUSPECT PRODUCT DETAILS (STRENGTH, NDC, BATCH NUMBER, EXP. DATE), PROCEDURE. EVENT NO ADVERSE EVENT WAS DELETED NEW EVENT HOSPITALISATION WAS ADDED. EVENT VERBATIM UPDATED FOR DEVICE DEFECTIVE AND NARRATIVE UPDATED. THE PATIENT WAS BEING TREATED WITH LIORESAL (BACLOFEN) INJECTION 40 MG/20 ML (2000 MCG/ML), INTRATHECALLY (NDC: 70121-2503-1, LOT NO: 8325201, EXP.DATE: 03-JUL-2027, LOT NUMBER ON KIT WITH THE TUBING: MS1435 AND SERIAL NUMBER: (B)(6)) (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. HISTORY OF PROCEDURE INCLUDED MEDICAL DEVICE IMPLANTATION AND MEDICAL DEVICE REPLACEMENT ON (B)(6) 2026. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF ALLERGIES, SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE CONNECTOR TUBING THAT CAME WITH IT BACLOFEN KIT WAS NOT PATENT WHILE DOING REFILL ON A PATIENT. NO AIR OR FLUID FLOWED THROUGH THE TUBING; THE TUBING WAS CONFIRMED TO BE UNCLAMPED AT THE TIME. THEY BELIEVE THIS IS THE SECOND TIME THIS HAPPENED. UNFORTUNATELY, THE TUBING WAS NOT SAVED/SEQUESTERED TO SEND BACK. ON (B)(6) 2026, THEY PERFORMED A RESERVOIR CHECK FOR A HOSPITALIZED PATIENT. SINCE THEIR INPATIENT PHARMACY ONLY HAD 20CC KITS IN STOCK AND THEY INTENDING TO REFILL THE PATIENT'S 40CC PUMP, SO THEY HAD TWO BOXES AT BEDSIDE, EACH CONTAINING A REFILL KIT AND ONE 20CC MEDICATION VIAL. THEY OPENED ONE OF THE REFILL KITS AND, BECAUSE OF WHAT HAD HAPPENED A FEW WEEKS PRIOR, THEY CHECKED THAT AIR WAS FLOWING THROUGH THE TUBING DURING SETUP. THEY FOUND THAT IT WAS AGAIN NOT PATENT, SO THEY OPENED THE SECOND REFILL KIT, CHANGED GLOVES, AND PERFORMED AN UNCOMPLICATED RESERVOIR CHECK AND REFILL USING THE TUBING FROM THE SPARE KIT. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO HOSPITALISATION WAS UNKNOWN. DE-CHALLENGE AND RE-CHALLENGE WERE UNKNOWN. LAST ACTION TAKEN WITH LIORESAL IN RELATION TO DEVICE DEFECTIVE WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS HOSPITALISATION AND DEVICE DEFECTIVE WAS UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF DEVICE DEFECTIVE AS RELATED TO THE LIORESAL REFILL KIT AND DID NOT ASSESS THE CAUSALITY OF EVENT HOSPITALISATION WITH RESPECT TO LIORESAL. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10